Wealy

GUDID 06971603580531

Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection.

Shantou Wealy Medical Instrument Co., Ltd.

Metered-delivery hypodermic syringe

• Primary Device ID: 06971603580531
• NIH Device Record Key: 98ad80c6-e423-4939-873e-f4ec58aff6fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wealy
• Version Model Number: 3ml 25Gx1"
• Company DUNS: 545570186
• Company Name: Shantou Wealy Medical Instrument Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971603580500 [Primary]
GS1	06971603580531 [Package]; Contains: 06971603580500; Package: box [100 Units]; In Commercial Distribution
GS1	06971603580562 [Package]; Package: carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141640

FDA Product Code

• MEG: Syringe, Antistick

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

[06971603580531]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-03
• Device Publish Date: 2021-04-25

On-Brand Devices [Wealy]

• 06971603580319: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603580357: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580340: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580289: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580371: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580517: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603580586: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603580531: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603585239: The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and